Medical Gas Pipeline Systems: Design, Installation, Validation and Verification

Medical gas pipeline systems Design, installation, validation and verification Health Technical Memorandum 2022

London: The Stationery Office

© Crown copyright 1997. Published with permission of NHS Estates, an Executive Agency of the Department of Health, on behalf of the Controller of Her Majesty’s Stationery Office. Applications for reproduction should be made in writing to The Copyright Unit, Her Majesty’s Stationery Office, St Clements House, 2–16 Colegate, Norwich NR3 1BQ. First published 1997

ISBN 0-11-322067-7

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About this series

Health Technical Memoranda (HTMs)

They are applicable to new and existing

give comprehensive advice and

sites, and are for use at various stages

guidance on the design, installation and

during the inception, design,

operation of specialised building and

construction, refurbishment and

engineering technology used in the

maintenance of a building.

delivery of healthcare.

Executive summary

An MGPS is installed to provide a safe, convenient and cost-effective system for the provision of medical gases to the clinical and nursing staff at the point of use. It reduces the problems associated with the use of gas cylinders such as safety, porterage, storage and noise. The guidance given in this HTM should be followed for all new installations, and for refurbishment or upgrading of existing installations. It is not necessary to apply the guidance retrospectively unless patient or staff safety would be compromised. In this case, the guidance given in this HTM should be followed. Existing installations should be assessed for compliance with this HTM. A plan for upgrading the existing system should be prepared, taking account of the priority for patient safety. Managers will need to liaise with medical colleagues and take account of other guidance published by the Department of Health in order to assess the system for technical shortcomings.

This volume of Health Technical Memorandum (HTM) 2022 looks at issues of design, installation, verification and validation. It covers the user requirements for flow, pressure and diversity and gives technical guidance on the design, installation and accommodation of plant and medical pipeline distribution systems. In addition, this volume describes the procedures to be carried out before a medical gas pipeline system (MGPS) can be taken into use. The tests to be carried out at each stage of the installation programme are set out, together with requirements for personnel, instrumentation and documentation required. This volume is intended for use by designers, installers, manufacturers, operational managers, engineers, quality controllers, technicians, finance officers and other professionals involved in the day-to-day running of an MGPS. The primary objective of this volume is to ensure the provision of safe and reliable MGPS and their efficient operation and use. This objective will only be achieved if the medical and nursing users and estates staff participate in the introduction of an operational policy designed to minimise the hazards likely to arise from misuse of the system.

Contents

1.0 1.1 1.6 1.7

Scope page 7 Guidance in this document Other guidance Design installation and testing

2.0 2.1 2.8 2.11

General principles page 8 General statement Quality requirements for medical gases and air Odour and moisture 2.11 Odour 2.13 Moisture Pipeline distribution system design Safety Installation/supply of equipment/maintenance Modifications Removal of pipework Validation and verification General fire precautions 2.30 General 2.32 Fire detection system Electricity supply to medical gas installations 2.33 General 2.40 Earthing 2.42 Installation of electrical cables 2.45 Electrical wiring in plantrooms Electrical supply pendants 2.49 Ceiling pendant fittings – rigid, multipurpose type 2.50 Bed head trunking/walling system

4.49

4.63

2.16 2.19 2.24 2.25 2.28 2.29 2.30

2.33

2.49

3.0 3.1 3.18 3.19 4.0 4.1 4.10

4.21

4.40 4.43 4.47

Provision of terminal units page 15 General Terminal units for nitric oxide, oxygen/carbon dioxide mixture Nitrogen for surgical tools Gas flow page 21 General Gas flow 4.10 Terminal unit flows 4.13 Pipeline flows Oxygen 4.21 In-patient accommodation 4.27 Hyperbaric oxygen chambers 4.28 Operating departments 4.32 Intensive therapy and coronary care units 4.36 Maternity Nitrous oxide Nitrous oxide/oxygen mixtures Medical air 4.47 General

4.71

5.0 5.1

5.23

5.33

6.0 6.1

Medical air 400 kPa 4.49 General 4.55 Pressure requirements 4.59 In-patient accommodation Surgical air 700 kPa 4.63 Flow and pressure requirements for 700 kPa surgical air system 4.66 Diversity 4.68 System capacity 4.69 Terminal units intended for equipment testing Vacuum 4.71 In-patient accommodation 4.75 Operating departments 4.82 Intensive therapy unit, coronary care unit and neonatal unit System design – General page 35 Cylinder manifold installation 5.1 General 5.9 Pressure control 5.14 Manifold monitoring and indicating system 5.16 Manifold control unit 5.17 Manifold monitoring 5.18 Manifold indication unit 5.19 Alarm signal status unit Emergency reserve supply 5.23 General 5.31 Emergency reserve supplies for manifold installations Emergency reserve supply for air compressors/liquid oxygen/oxygen concentrators (PSA) 5.34 Location 5.35 Design System design – Oxygen supplies page 42 Bulk liquid oxygen systems and vacuum insulated evaporator (VIE) 6.1 General 6.5 System sizing 6.9 Equipment description 6.10 Standby oxygen facility 6.11 System layout 6.12 VIE 6.15 Control piping and instrumentation 6.17 Pressure raising system 6.19 Direct reading contents gauge and telemetry systems 6.26 Control panel 6.27 Sites for liquid oxygen storage 6.30 Operation 6.32 Standby system in use

1

Contents

6.62

6.89

7.0 7.1

2

6.35 Standby low 6.36 Low line pressure 6.37 High line pressure 6.39 VIE filling 6.40 Maintenance 6.42 Standby oxygen facility 6.45 Backup bulk liquid storage vessel 6.48 Liquid cylinder backup 6.50 Compressed gas cylinder backup 6.52 Emergency supply facility 6.58 Alarm signal status unit Liquid oxygen supplies 6.62 General 6.65 Liquid cylinder design 6.67 Liquid cylinder manifolds 6.69 Control panel 6.71 Emergency compressed oxygen manifold 6.72 Siting requirements 6.82 Liquid cylinder manifold sizing 6.84 Refilling 6.85 Alarm signal status unit Oxygen concentrator installations (PSA plant) 6.89 General 6.94 Siting 6.98 Plant configuration 6.100 Compressors and vacuum pumps 6.102 Compressor noise 6.104 Molecular sieves 6.105 Dryers 6.106 Oxygen monitoring system 6.107 Operating and indicating system 6.111 Plant control unit 6.115 Plant control indication 6.116 Compressor and vacuum starter units 6.117 Molecular sieve control unit 6.119 Plant status monitoring 6.120 Plant indicator unit 6.124 Alarm signal status unit 6.129 Plant management System design – Medical air page 67 Compressor systems for 400 kPa medical air 7.1 General 7.2 Quality 7.3 Siting 7.7 Compressor noise 7.9 Air intake 7.10 Compressor types 7.13 Compressor lubrication 7.21 After-coolers 7.22 Receivers 7.24 Air treatment and filtration 7.24 General 7.25 Solid contaminants 7.29 Water 7.31 Oil 7.39 Dryer controls 7.40 Dust filters

7.79

8.0 8.1 8.9 8.11 8.13

8.30 8.31 8.32

7.42 Activated carbon filter 7.43 Bacteria filters 7.44 Pressure control 7.45 Test point 7.46 Safety valves 7.48 Traps and valves 7.48 Automatic drainage traps 7.50 Non-return valves 7.51 Isolating valves 7.52 Pressure indicators 7.53 Operating and indicating system 7.61 Plant control unit 7.64 Plant control indication 7.65 Compressor starter units 7.66 Dryer control unit 7.68 Plant status monitoring 7.69 Plant indicator unit 7.72 Alarm signal status unit 7.77 Plant management 7.78 Operating considerations Synthetic air 7.79 General 7.88 System description 7.95 Storage vessels 7.95 Vessel summary 7.96 Vessel operating pressure 7.97 Main vessel capacity 7.98 Backup vessel capacity 7.104 Vaporisation 7.109 Medical oxygen flow control 7.110 Surgical nitrogen flow control 7.112 Control panel for the nitrogen and oxygen supplies to the mixing panels 7.116 Air mixing panels 7.121 Buffer vessels 7.124 Alarm signal status unit 7.128 Emergency supply facility System design – surgical air 700 kPa page 86 General Cylinder manifold supply systems Compressor supply systems Operating and alarm system 8.13 Cylinder manifold supply system 8.13 Manifold monitoring and indicator system 8.14 Manifold monitoring 8.15 Manifold indicator unit 8.16 Alarm signal status unit 8.20 Compressor supply system 8.21 Plant status monitoring 8.22 Plant indicator unit 8.25 Alarm signal status unit Plant management Operating considerations Simplex plant

Contents

9.0 System design – medical vacuum supplies page 90 9.1 Medical vacuum supplies 9.1 General 9.9 Siting 9.11 Pump noise 9.13 Vacuum plant exhaust 9.16 Efficiency 9.18 Vacuum pumps 9.35 Pressure control 9.37 Valves 9.39 Pressure regulation of vacuum system 9.42 Vacuum indicators 9.44 Electrical supply 9.45 Pump operating and indicating system 9.45 General description 9.49 Plant control unit 9.53 Plant control indication 9.54 Pump starter units 9.55 Plant status monitoring 9.56 Plant status indicator unit 9.58 Alarm signal status unit 9.62 Plant management 10.0 System design – anaesthetic gas scavenging systems page 100 10.1 Anaesthetic gas scavenging systems 10.1 General 10.10 Background 10.18 Sources of pollution and provision of AGS systems 10.32 AGS system design 10.32 General 10.35 Active and passive systems 10.40 General design requirements 10.46 Safety criteria 10.48 Performance criteria 10.51 Flow diversity 10.52 Discharge outlet 10.53 Duplex system 10.54 Plant control indication 11.0 11.1

System design – Nitric oxide page 109 Nitric oxide pipeline installations 11.1 Introduction 11.5 Design considerations 11.10 Provision of terminal units, valves and area valve service units (AVSUs) 11.14 Manifold 11.22 Provision of valves 11.24 Provision of AVSUs 11.28 Pipeline distribution 11.29 Identification 11.30 Alarm systems 11.32 Nitric oxide – risk assessment for COSHH compliance 11.38 Validation and verification

12.0 12.1 12.7

12.10 12.11

12.13

12.31

12.37

12.49

12.54

12.59

Warning and alarm systems page 114 General Panel location 12.7 Central indicator panel 12.8 Repeater indicator panel location 12.9 Area warning and alarm panel location System description 12.10 System components System layout 12.11 Central system 12.12 Area warning and alarm systems General requirements 12.13 Labelling 12.14 Visual signals 12.17 Audible signals 12.18 Automatic re setting 12.19 Temporary muting 12.20 Continuous muting 12.21 Electrical wiring 12.22 System integrity 12.25 Relay condition 12.26 Mains power supply 12.27 SELV/FELV power supply 12.30 Test facility Warning and alarm system faults 12.31 General 12.32 Line fault 12.33 Communication/wiring fault 12.34 Mains power failure 12.35 Standby battery 12.36 Legend Indicator panel requirements for all systems 12.37 Indicators 12.40 Labelling 12.41 Construction 12.48 Remote audible sounder Central indicator panel requirements 12.49 Displays 12.50 Mute functions 12.53 Panel legend and display Repeater indicator panel requirements 12.54 Displays 12.55 Mute functions 12.58 Panel legend and display Area warning and alarm panel 12.54 Displays 12.60 Mute functions 12.62 Panel legend and display 12.63 Location

13.0 13.1 13.9

Pipeline installation page 126 Accommodation of pipes Pipeline materials 13.10 Quality 13.12 Pipes 13.14 Other fittings 13.15 Cleaning 13.15 Pipes

3

Contents

13.16 Pipe joining fittings 13.18 Pipeline jointing 13.18 General 13.27 Jointing methods 13.30 Pipe preparation 13.31 Use of N2 internal inert gas shield 13.31 Application 13.33 Safety 13.34 Control cylinders 13.35 Other installation processes 13.36 Inspection of joins 13.37 Internal cleanliness 13.38 Penetration 13.39 Capping 13.40 Removal of flux residues and oxides 13.45 Purging with the working gas 13.46 Pipe supports 13.52 Identification of pipelines 13.54 Pipeline fittings 13.54 General 13.55 Ceiling pendant fittings rigid, multi-purpose type 13.61 Flexible pendant fitting 13.62 Bed head trunking/walling system 13.67 Shut-off valves 13.68 Provision of valves 13.70 Area valve service units (AVSUs) 13.75 Provision of AVSUs 13.75 General 13.79 Labelling 13.81 Pressure sensors 13.82 Pressure gauges 13.83 Test points 13.84 Emergency inlet port 13.86 Line pressure alarms and safety valves 14.0 14.1

14.11 14.14 14.22 14.23 15.0 15.1 15.14

15.17

15.37

4

Accommodation page 138 Design and construction of plantrooms 14.1 Location of plantrooms 14.7 Access Construction and layout of manifold rooms Heating and ventilation of plantrooms Lighting Noise control Validation and verification page 141 General Summary of tests 15.14 Tests and checks on the pipeline carcass 15.15 Test on the pipeline system 15.16 Tests before use General requirements for testing 15.17 General 15.29 Modifications,extensions or repairs to existing systems Requirements for pipeline carcass tests 15.37 Labelling and marking 15.38 Sleeving and supports 15.39 Leakage

15.44

15.79 15.86 15.88

15.106 15.111

15.115 15.116 15.117 15.118 15.123

15.134 15.140

15.43 Cross-connection Requirements for pipeline system tests 15.44 Leakage from total compressed medical gas systems 15.49 Leakage into total vacuum systems 15.50 Closure of area valve service units 15.54 Zoning of AVSUs and terminal unit identification 15.58 Cross-connection 15.63 Flow and pressure drop at terminal units 15.64 Mechanical function of terminal units 15.65 Gas specificity of terminal units 15.66 NIST connectors 15.68 Performance tests of the pipeline system 15.72 Functional tests of supply systems 15.74 Pressure safety valves 15.76 Warning systems 15.78 Verification of as-fitted drawings Filling with medical air Purging and filling with specific gases Quality of compressed medical gas systems 15.88 General 15.95 Particulate matter 15.97 Oil 15.99 Water 15.101 Carbon monoxide 15.102 Carbon dioxide 15.104 Nitrogen 15.105 Pipeline odour Gas identification Requirements before a MGPS system is taken to use 15.111 General Operational policy Cylinder storage and handling Removal of construction labels Anaesthetic gas scavenging systems 15.118 General Performance tests: disposal systems 15.123 Powered device 15.125 Pipework/ductwork installation 15.127 Performance testing 15.139 Receiving system Performance efficiency Methods and procedures for validation and verification of medical gas pipeline systems 15.140 General 15.146 Labelling and marking 15.148 Sleeving and supports 15.150 Leakage 15.154 Cross-connection 15.157 Leakage from compressed medical gas systems 15.160 Leakage into vacuum system 15.163 Closure of AVSUs 15.166 Zoning of AVSUs 15.170 Cross-connection

Contents

15.174 Functional tests of terminal units 15.176 Performance tests of the pipeline system 15.179 System supply tests 15.184 Safety valve inspection 15.187 Warning system tests 15.191 Verification of drawings 15.193 Filling with medical air 15.197 Purging and filling with specific gas 15.200 Tests for quality 15.203 Tests for gas identity 15.206 System taken into use Appendix A – Testing, commission and filling for use: Forms to be completed during testing and commissioning of piped medical gases systems page 173 Appendix B – Gas pressure variation with temperature page 191 Appendix C – Pressure drop test device page 192 Appendix D – Membrane filter test device page 194 Appendix E – Equipment for contaminant testing page 196 Appendix F – Equipment for gas identification page 197 Appendix G – Procedures for measuring the design flow of vacuum plant page 199 Appendix H – Procedure for measuring pipeline volume page 200 Appendix J – Pressure loss data page 202 Appendix K – Pressure regulation for 400 kPa (medical gases and medical air) and 700 kPa systems (surgical air) page 208 References page 211 Other publications in this series page 213 About NHS Estates page 214

5

6

1.0 Scope

Guidance in this document

Other guidance

1.1 Guidance in this volume of Health Technical Memorandum (HTM) 2022 covers piped medical gases, medical compressed air and medical vacuum installations, and applies to all medical gas pipeline systems (MGPS) installed in healthcare premises.

1.6 Guidance on the provision of MGPS is given in the Health Building Notes.

1.2 An MGPS is installed to provide a safe, convenient and cost-effective system for the provision of medical gases to the clinical and nursing staff at the point of use. It reduces the problems associated with the use of gas cylinders such as safety, porterage, storage and noise. 1.3 The guidance given in this volume should be followed for all new installations and refurbishment or upgrading of existing installations. 1.4 It is not necessary to apply the guidance retrospectively unless patient or staff safety would be compromised. In this case, the guidance given in this volume should be followed.

Design, installation and testing 1.7 This volume of HTM 2022 deals with the issues involved in the design, installation and testing of an MGPS. 1.8 The standard specification, Model Engineering Specification C11, supports this HTM. C11 provides details of the extent of the works required and is a procurement specification. 1.9 Whenever appropriate, British Standard specifications should be used.

1.5 Existing installations should be assessed for compliance with this volume. A plan for upgrading the existing system should be prepared, taking account of the priority for patient safety. Managers will need to liaise with medical colleagues and take account of other guidance published by the Department of Health in order to assess the system for technical shortcomings.

7

2.0 General principles

General statement 2.1 An MGPS is designed to provide a safe and effective method of delivering the required medical gas from the source of supply through a pipeline system to the patient via a terminal unit. 2.2 Each medical gas must be supplied from a separate system, and it is essential that all parts of each system are gas specific to ensure that there is no possibility of cross-connection between any system. A schematic diagram of a typical MGPS is shown in volume 1 of this HTM, ‘Operational management’ (Figure 1). 2.3 Systems for dental air and vacuum are covered in HTM 2022 Supplement 1, ‘Dental compressed air and vacuum systems’, since the requirements are different. However, where anaesthetic gases are administered in dental departments, the guidance given in this HTM should be followed. 2.4 During the installation stage, extensive tests are carried out to verify that there is no cross-connection. 2.5 other stage given

Where medical air 400 kPa is to be used for testing surgical tools and medical equipment, this requirement should be considered at the design to ensure that sufficient capacity is available. Details of design flows are in Chapter 4 “Gas flow”.

2.6 MGPS should not be used to supply pathology departments, general workshops or mechanical services. The 400 kPa medical air system may, however, be extended to those departments where respiratory equipment or surgical tools are serviced, such as in sterile disinfection units (SDUs), electronic and biomedical equipment (EBME) workshops etc. In such cases only, to facilitate the testing and checking of operation of equipment for the different medical gases, all terminal units (excluding vacuum) may be connected to the medical air supply and be provided with simplified alarm facilities and labelled accordingly. 2.7 Separate installations should be provided for pathology and general laboratories and workshops, although it is recommended that they are constructed to the same specification as MGPS. They should not be provided with medical gas terminal units. Piped medical vacuum systems are not recommended for infectious disease units.

Quality requirements for medical gases and air 2.8 Medical gases supplied from cylinder or liquid sources comply with the appropriate sections of the current edition of the European Pharmacopoeia (Ph Eur). There is currently no Ph Eur for site-generated medical air and oxygen pressure swing adsorber (PSA) systems. The quality specification for medical air is as given in Table 1.

8

2.0 General principles

2.9 The introduction of the new Ph Eur for medical air will be effective from 1998 and therefore medical air will need to comply with this new specification. The Ph Eur also specifies validation protocols which will need to be adopted. 2.10 The quality of piped medical compressed air, the particulate content, dryness and concentration of impurities, should comply with the requirements for maximum concentrations given in Table 1, which is based on the specification for breathing air in BS EN 132:1991. Information on testing procedures is given in Chapter 15, ‘Validation and verification’. Table 1 Quality specification for medical air (for the requirement for dental compressed air refer to the relevant supplement) Parameter

Specification

Oxygen

20.9 +/–1.0%

Nitrogen

78% by inference

Particulate contamination

Practically free from visible particles in a 75 l sample

Water content – see paragraph 2.13

115 vpm (0.095 mg/l) (equivalent to dewpoint –40ºC at atmospheric pressure)

CO

5 ppm v/v

CO2

500 ppm v/v

Oil content (droplet or mist)